A Safety Trial for Evaluating Patient Specific Guides Accuracy for Pedicle Screw Insertion in Lumbar Fusion
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Screw trajectory deviation
研究概览
简要总结
This is a single centre, non-blinded safety trial. Patients undergoing lumbar fusion will be treated using patient specific guides (PSG) or navigation. Patients requiring lumbar fusion will be treated using conventional surgical methods except when inserting pedicle screws, where half of the patients will be having screws inserted using PSGs. The conventional method of navigation and intraoperative imaging will be used in conjunction with PSGs, to confirm the safety of the guide trajectory. The primary outcome will be screw accuracy measured in degrees from planned trajectory and mm from the planned entry point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Indication for lumbar spine surgery requiring pedicle screw instrumentation through a posterior approach with fusion.
- •Recently has or requires a CT-scan of the spine
- •No previous spine surgery on the level being used for patient specific guides
- •Sufficient understanding of the English language or interpretation assistance available.
排除标准
- •History of alcohol or drug abuse
- •History of psychiatric disorders
- •Previous spine surgery adjacent or at the level of the surgery
- •Unable to read or comprehend the consent form/letter of information
结局指标
主要结局
Screw trajectory deviation
时间窗: Day 1
Measured as the angle in degrees deviated from the planned trajectory
Screw start point deviation
时间窗: Day 1
Measured as distance in millimeters from the planed start point.
次要结局
- Guide Reliability(Day 1)
- Adverse Event Rate & Serious Adverse Events(Day 1, Day 3, 6 weeks, 12 weeks, 26 weeks)
- Pedicle Breach(Day 1)